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arrow seldinger arterial catherization devices models ex sac 00520
Arrow Intl.
Summary: The Arrow Seldinger Arterial Catheterization Devices are used for arterial access, primarily in critical care and surgical settings. They are typically used by anesthesiologists, intensivists, and surgeons.
FDA Clearance Information
Pathway
510K
Number
K093050 ↗
Decision Date
December 18, 2009
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on December 18, 2009. Manufactured by Arrow Intl., it is classified as a Class 2 device under product code DQY.
What It Is
The Arrow Seldinger Arterial Catheterization Devices are designed for arterial access using the Seldinger technique, which involves inserting a catheter over a guidewire. This method is commonly used to obtain arterial blood samples, monitor blood pressure, and administer medications directly into the arterial system.
Clinical Applications
These devices are commonly used in critical care units, operating rooms, and emergency departments. They are essential for procedures requiring continuous blood pressure monitoring or frequent arterial blood gas sampling. The devices are used in adult and pediatric populations, particularly in patients requiring intensive monitoring or those undergoing major surgeries.
Indications for Use
The device is indicated for use in patients needing arterial access for monitoring, blood sampling, or medication administration. It is suitable for conditions requiring precise hemodynamic management, such as in critically ill patients or during complex surgical procedures.
Practical Considerations
The devices are available in various sizes to accommodate different patient anatomies and clinical needs. They are compatible with standard monitoring equipment and require familiarity with the Seldinger technique for safe and effective use.
Frequently Asked Questions
What is the Arrow Seldinger Arterial Catheterization Device used for?
It is used for arterial access to monitor blood pressure, obtain blood samples, and administer medications.
What specialties typically use this device?
Anesthesiologists, intensivists, and surgeons commonly use this device in critical care and surgical settings.
What are the FDA-cleared indications?
The device is indicated for arterial access in patients requiring monitoring, blood sampling, or medication administration.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.